Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure

Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01872767

Enrollment

522

Registered

2013-06-07

Start date

2013-06-30

Completion date

2014-11-30

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Failure, Chronic Liver Failure, Cirrhosis

Keywords

Acute on Chronic Liver Failure (ACLF),Cirrhosis,, Institute of Liver & Biliary Sciences (ILBS)

Brief summary

After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure). * Age \> 18years

Exclusion criteria

* Previous liver transplantation. * Patients who died within 8 hours of ICU (Intensive Care Unit) admission. * Acute liver failure * Lack of consent * Patient on steroids/ or any other immunosuppressive medication

Design outcomes

Primary

Measure	Time frame
Mortality within 1 month during ICU (Intensive Care Unit) stay.	30 days

Secondary

Measure	Time frame
Number of days stayed in ICU (Intensive Care Unit).	30 days
Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc	30 days
Proportion of patients with organ failure.	30 days

Countries

India

Outcome results